25 August 2012

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US Federal Appeals Court Rejets graphic cigarette label requirement Rule Law

US Federal Appeals Court Rejets graphic cigarette label requirement Rule Law

United States Court of Appeals
Argued April 10, 2012
Decided August 24, 2012

The Family Smoking Prevention and Tobacco Control Act (“the Act”) directed the Secretary of the U.S. Department of Health and Human Services to issue regulations requiring all cigarette packages manufactured or sold in the United States to bear one of nine new textual warnings, as well as “color graphics depicting the negative health consequences of smoking.”

Pursuant to this authority, the Food and Drug Administration (“FDA”) initiated a rulemaking proceeding through which it selected
the nine images that would accompany the statutorily-prescribed warnings.  Five tobacco companies  challenged the rule, alleging that FDA’s
proposed graphic warnings violated the First Amendment.

The Companies also alleged the graphic warnings violated the Administrative Procedure Act (“APA”).

But companies said graphic warnings violate the First Amendment, we do not reach the Companies’ APA claims.

The Act gives FDA the authority to regulate the manufacture and sale of tobacco products, including cigarettes.  In addition to requiring cigarette packages and advertisements to bear one of nine new warning statements, the Act mandates that the new warning labels comprise the top 50 percent of the front and rear panels  of cigarette packages and 20 percent of the area of each cigarette advertisement.  Act § 201(a), 123 Stat. at 1842–45.  The Act directs the Secretary to issue final regulations identifying the graphic component of the warnings by June 22, 2011, and provides that the revised health warnings will take effect by September 22, 2012.

FDA promulgated the final set of nine images—one for each warning statement—by regulations issued on June 22, 2011.

FDA also required each graphic image to bear the phone number of the National Cancer Institute’s “Network of Tobacco Cessation Quit lines,” which uses the telephone portal “1-800-QUIT-NOW.”

In selecting  nine images, FDA reviewed and responded to over a thousand public comments

FDA’s research study failed to provide evidence that the proposed warnings would actually affect smoking rates, significantly affect consumer’s knowledge of the risks of smoking, or bring about actual behavior change.

FDA disagreed, again relying on the “substantial research” showing the effectiveness of similar graphic health warnings in other countries.

Tobacco manufacturers also criticized the “study’s use of intentions to measure behavioral change and stated that FDA should have presented data showing actual effects on behavior.”

the Companies noted that the Canadian data revealed  no statistically significant decline in smoking rates for adolescents and adults after the introduction of similar graphic warnings, which implied that the warnings
were ineffective and that FDA’s warnings would be ineffective as well.

After FDA finalized the Rule, the Companies filed suit in the district court, claiming the cigarette warnings required under the Act and FDA’s implementing regulations violated the First Amendment.  The district court granted the Companies’ motion for a preliminary injunction on November
7, 2011,

The Companies do not dispute Congress’s authority to require health warnings on cigarette packages, nor do they challenge the substance of any of the nine textual statements mandated by the Act.

The only question before us is whether FDA’s promulgation of  the graphic warning labels—, which incorporate the textual warnings, a corresponding graphic image, and the “1-800-QUIT-NOW” cessation hotline number—violates the First Amendment.

This case contains  elements of compulsion and forced subsidization.  The Companies contend that, to the extent the graphic warnings go beyond the textual warnings to shame and repulse smokers and denigrate smoking as an antisocial act, the message is ideological and not informational.

 “[B]y effectively shouting well-understood information to consumers,” they explain, “FDA is communicating an ideological message, a point of view on how people should live their lives: that the risks from smoking outweigh the pleasure that smokers derive from it, and that smokers make bad personal decisions, and should stop smoking.”  In effect, the graphic images are not warnings, but admonitions:  [D]on’t buy or use this product.            

The question here is whether the graphic warnings actually  do constitute the type of disclosure requirements that are reviewable
No one doubts the government can promote smoking cessation programs; can use shock, shame, and moral opprobrium to discourage people from becoming smokers; and can use its taxing and regulatory authority to make smoking economically prohibitive and socially onerous.  And the government can certainly require that consumers be fully informed about the dangers of hazardous products. 

But this case raises novel questions about the scope of the government’s authority to force the manufacturer of a product to go beyond making purely factual and accurate commercial disclosures and undermine its own
economic interest—in this case, by making “every single pack of cigarettes in the country [a] mini billboard” for the government’s anti-smoking message.

In the Proposed Rule, FDA lamented that their previous efforts to combat the tobacco companies’ advertising campaigns have been like bringing a butter knife to a gun fight. 

According to the FTC, tobacco companies spent approximately $12.49 billion on advertising and promotion in 2006 alone, employing marketing and advertising experts to incorporate current trends and target their messages toward certain demographics. 

Proposed Rule at 69,531.  The graphic warnings represent FDA’s attempt to level the playing field, not only by limiting the Companies’ ability to advertise, but also by forcing the Companies to bear the cost of
disseminating an anti-smoking message.

But as the Supreme Court recently reminded us, “that the [government] finds expression too persuasive does not permit it to quiet the
speech or to burden its messengers.”   Sorrell v. IMS Health Inc., 131 S. Ct. 2653, 2671 (2011). 

The First Amendment requires the government not only to state a substantial interest justifying a regulation on commercial speech, but also to show that its regulation directly advances that goal.

FDA failed to present any data—much less the substantial evidence
required under the APA—showing that enacting their proposed graphic warnings will accomplish the agency’s stated objective of reducing smoking rates. 

The Rule thus cannot pass muster under Central Hudson. 

In a 2-1 decision, the US Court of Appeals in Washington said that the images planned on cigarette packs were not necessarily false but they went beyond "pure attempts to convey information to consumers."

"They are unabashed attempts to evoke emotion (and perhaps embarrassment) and browbeat consumers into quitting," Judge Janice Rogers Brown

Beginning in 1965, the government undertook to warn consumers of the health risks associated with smoking by requiring the inclusion of a health warning on the side of cigarette packages.   See  Federal Cigarette Labeling and Advertising Act of 1965, Pub. L. No. 89-92, 79 Stat. 282 (1965).

Congress last revised the content and format of these warning labels in 1984.  See Comprehensive Smoking Education Act of
1984, Pub. L. No. 98-474, 98 Stat. 2200 (1984).  Since then, “evidence regarding the ineffectiveness of the prescribed warnings has continued to accumulate,” supporting the conclusion that these warnings “are unnoticed and stale, and they fail to convey relevant information in an effective way.”
IOM Report at 291.

Because the warning label requirement (absent the “1-800-QUIT-NOW” number) appears to survive the First Amendment challenge under either Zauderer or Central Hudson.

FDA said that many other countries got the laws for the graphic warnings.

Brown said that other countries "do not necessarily protect individual liberties as stringently as does the United States Constitution."

Photos showing FDA Suggested nice Cigarate Graphic Images –

Photo Source - http://www.usatoday.com

Suggested Reading –

USA – First Amendment Understand Know everything about First Amendment First Amendment Soul of American Constitution

Know 25 Ways, Methods to quit smoking. Thirteen  Disadvantages of smoking Smoking  Kills you , your loved once


Reality views by sm –

Saturday, August 25, 2012

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MEcoy August 25, 2012  

OUR COUNtry also had this idea i think thats a great move

virendra sharma August 25, 2012  

Smoking is the mother of all addictions like daibetes the mother of all diseases.Good job SM.